NCT06453161Completed
Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery: a Retrospective Monocentric Cohort Study
Source: ClinicalTrials.gov · Last updated 11 Jun 2024
Brief summary (registry, in English)
Cardiac surgery with cardiopulmonary bypass exposes patients to the risk of post-operative acute kidney injury. In the specific setting of cardiac surgery, acute kidney injury is often of multifactorial origindue to particular haemodynamic mechanisms, renal hypoxia, or damage linked in the inflammatory reaction or haemolysis (1). In recent years, inhibitors of the sodium/glucose co-transporter type 2 (SGLT2i) have demonstrated their relevance in reducing the morbidity and mortality associated with chronic or acute heart failure and chronic kidney disease. These drugs were initially developed to optimise glycaemic control in diabetic patients. They are currently recommended as part of the management of diabetic patients at high cardiovascular risk, patients with systolic and/or diastolic heart failure, and patients with chronic kidney disease. Some pharmacodynamic properties of SGLT2i suggest that they could have a beneficial effect in preventing the onset of acute kidney injury, but also that they could lead to potentially deleterious effects in renal haemodynamic in specific situations. The aim of the study was to estimate the impact of pre-operative exposure to SGLT2i on the occurrence of post-operative acute kidney injury in high-risk renal patients undergoing cardiac surgery.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 500 (actual)
- First submitted
- 7 Jun 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 10 Apr 2024
- Lead sponsor
- Hospices Civils de Lyon
- NCT number
- NCT06453161
What you commit to
- Study type: Observational
- Participants enrolled: 500
- From 1 Apr 2024 to the primary completion date, 10 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Haemodialysis prior to surgery
- Acute kidney injury prior to surgery as defined in the primary endpoint. If this criterion is not available, patients will only be included if glomerular filtration rate estimated by the CKD-EPI formula is ≥75 mL/min/1.73m2.
Other
- Death in the operating theatre
- Opposition of the patient to the use of his/her health data
Who the study is looking for
- Age ≥ 18 years
- Cardiac surgery with cardiopulmonary bypass
- Presenting a simplified renal risk score ≥ 2 points defined as follows:
- Pre-operative glomerular filtration rate (≤ 60; ≤ 30 mL/min/1.73m2): 1-2 points
- Diabetes requiring treatment: 1 point
- LVEF ≤ 40%: 1 point
- Previous cardiac surgery: 1 point
- Pre-operative intra-aortic counter pulsation: 1 point
- Non elective surgery: 1 point
- Surgery other than closure of an atrial septal defect or coronary bypass surgery: 1 point
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital cardiologique Louis Pradel Groupe Hospitalier Est Coordinator of this site? Confirm its status | Bron | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.